The present patent application makes reference to and fully incorporates all information found in U.S. Pat. No. 8,998,827 issued Feb. 13, 2013 entitled Ellipticity Measuring Device, and U.S. patent application Ser. No. 14/683,055 filed Apr. 9, 2015 entitled Post Dilation Balloon With Marker Bands For Use With Stented Valves.
Mitral regurgitation (MR) can occur due to a dysfunction of the mitral valve leaflets or due to enlargement of the left ventricle (LV) and mitral annulus causing mitral leaflets to no longer coapt properly. To correct MR, a surgical procedure can be performed to support the mitral annulus from further enlargement or to repair or replace the mitral valve leaflets.
An alternate procedure that is less invasive can be performed via a catheter that is introduced either across the atrial septum or through the apex of the heart. This mitral transvascular valve replacement (MTVR) procedure is intended to place a synthetic, tissue, or composite stented valve within the native mitral valve. Determining an accurate diameter for the MTVR device within the noncircular mitral annulus can be difficult and failure to make an accurate diameter determination can result in a paravalvular leakage of blood around the stented MTVR. In addition, the MTVR can impose an outward force onto the anterior native mitral valve leaflet causing it to obstruct the flow of blood from the LV out of the left ventricular outflow tract (LVOT).
What is needed is a device that can be easily inserted across the mitral valve annulus prior to implantation of an MTVR to determine an accurate diameter for the mitral annulus and can further be used to identify if the MTVR will impact onto the native anterior mitral valve leaflet resulting in obstruction to the LVOT.